Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT06914557
Eligibility Criteria:
Inclusion Criteria:
1. Persons aged 18 years or older with cancer
2. Eastern Cooperative Oncology Group 0-2
3. At least a 4/10 average pain score prior to treatment
4. At least CTCAE version 5.0 grade 2 neuropathies.
5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.
6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
7. Patients must have discontinued neurotoxic chemotherapy within the last 3 months with no additional therapy planned for the next 6 months after initiation of CIPN treatment.
8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation
9. Patients must be able to provide informed written consent.
Exclusion Criteria:
1. Children or adolescents
2. Pregnant or nursing patients
3. Presence of an implantable life supporting medical device or implantable drug delivery system
4. Patients with severe skin conditions preventing the proper application of electrodes
5. Patients currently on monoamine oxidase inhibitors MAOIs.
6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).
7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)
8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed
9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder
10. Patients with uncontrolled epilepsy.
11. Patients who have previously attempted or undergone Scrambler therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06914557
Study Brief:
Protocol Section:
NCT06914557